MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS INLIN VLV SPHN/UNIT CAT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8806

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).Attempts are being made to obtain additional information.Upon receipt of new relevant information, a follow-up report will be submitted.

Event Description

As reported by the affiliate, after 11 days, a hakim valve was suspected of leaking and was revised.Initial setting were unknown.However, cerebrospinal fluid was confirmed to be collected around the implanted valve near the iliac bone.It was suspected that cerebrospinal fluid could be leaking, therefore, a revision surgery was performed.The product will be returned.There was no confirmation of pin holes or leakage from connection parts.

Manufacturer Narrative

Additional information: pma/510k, if follow-up, what type, device evaluated by mfr.The device was returned for evaluation.The valve was visually inspected; needle guard was slightly raised.The valve was tested for programming and passed.The valve was flushed; no occlusion was noted.The valve was leak tested; no leaks noted.The valve was reflux tested and passed.The siphon guard was teste; no issues found.The siphon guard was removed.The valve was then pressure tested and passed.A review of manufacturing records could not be performed, as no lot number was provided.Based on the results of the investigation, the reported issue could not be confirmed, the device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Udi: (b)(4).Additional information was received from the affiliate regarding the device involved in the reported event.This report has been updated with the corrected information.The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, after 11 days, a certas plus valve was suspected of leaking and was revised.Initial setting were unknown.However cerebrospinal fluid was confirmed to be collected around the implanted valve near the iliac bone.It was suspected that cerebrospinal fluid could be leaking, therefore, a revision surgery was performed.The product will be returned.There was no confirmation of pin holes or leakage from connection parts.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle MA CH 24 00; SZ CH 2400
• MDR Report Key: 8190387
• MDR Text Key: 131183022
• Report Number: 1226348-2018-10909
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-8806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR